BEUDAMED
    FDA Adverse Event Summary report: N

    MISTRAL AIR PLUS (115V) BLOWER

    MDR report key: 4360655 · Received December 17, 2014

    Report

    Report Number
    3003312341-2014-00016
    Date Received
    December 17, 2014
    Date of Event
    December 5, 2014
    Report Date
    December 17, 2014
    Manufacturer
    THE SURGICAL COMPANY INTERNATIONAL BV DBA THE 37COMPANY
    Product Code
    DWJ
    PMA / PMN Number
    K10705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MISTRAL AIR HAD A BURN MARK IN THE BLOWER HOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830288 MISTRAL AIR PLUS (115V) BLOWER DWJ THE SURGICAL COMPANY INTERNATIONAL BV DBA THE 37COMPANY MA1100-PM

    Patients

    Seq Age Sex Outcome Treatment
    1